CARDIOVASCULAR
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CardioMEMS™ HF System

PA Sensor and Delivery System

CardioMEMS™ HF System

PRODUCT HIGHLIGHTS

  • The CardioMEMS™ HF System is a FDA-approved heart failure (HF) monitor proven to significantly reduce HF hospital admissions and improve quality of life in NYHA Class III patients. When used by clinicians to manage HF, the CardioMEMS HF System is:
    - Safe and reliable -demonstrated 98.6% freedom from device or system complications1
    - Clinically proven - reduced HF admissions by 33%2,a
    - Proactive and personalized - patient management through direct montioring of PA pressure and titration of medications
  • The CardioMEMS HF System provides direct pulmonary artery (PA) pressure monitoring using the sensor, patient electronics system and the CardioMEMS HF System website to manage patient data. Patient-initiated sensor readings are wirelessly transmitted to an electronics unit and stored in a secure website for clinicians to access and review
  • The reliable radiopaque sensor is implanted in the pulomary artery using a delivery system via a safe and proven right-heart catheterization procedure1
  • In a clinical study with 1,167 patient years of experience:3
    no sensor failures (inability to obtain readings) were reported, indicating reliable PA pressure monitoring1
  • The sensor endothelializes, occupying on average about 10% of cross-sectional lumen for low risk of infection, thrombus or occlusion3
  • PA sensor pressure measurements (n = 85) showed agreement within 1.0 ± 4.7 (mean difference +/- sd) mmHg with a pulmonary artery catheter during follow-up measurements performed after an average follow-up of 265 ± 169 days post implantation without interim re-calibration4
  • The sensor is calibrated during manufacturing and the mean pressure baseline is matched to the pulmonary artery catheter mean pressure during the implant procedure. The sensor does not contain a battery or other components which would limit its usable life

ORDERING INFORMATION

Contents: PA Sensor and Delivery System


Reorder Number Description
CM2000 PA Sensor and Delivery System

1. Abraham, W. T., Adamson, P. B., Bourge, R. C., Aaron, M. F., Costanzo, M. R., Stevenson, L. W.,…Yaday, J. S., (2011). Wireless pulmonary artery haemodynamic monitoring in chronic heart failure: a randomized controlled trial. The Lancet, 377, 658-666. doi:10.1016/S0140-6736(11)60101-3.

2. Abraham, W. T., Stevenson, L., Bourge, R. C., Lindenfled, J., Bauman, J., and Adamson, P. B. (2016). Sustained efficacy of pulmonary artery pressure to guide to adjustment of chronic heart failure therapy: Complete follow-up results from the CHAMPION randomized trial. The Lancet, 387(10017), 453-461.

3. Data on File. G060187, September 2006. PMA P100045, December 2010. G060187/S031, August 2008.

4. The CardioMEMS Champion™ HF Monitoring System for Patients with NYHA Class III Heart Failure: Draft Briefing Document for the Circulatory Systems Device Panel Advisory Committee, December 8, 2011. P100045. Data on file.

a. 33% reduction in HF hospitalizations over an average 18 months of follow-up.


Rx Only

 

Brief Summary: Prior to using these devices, please review the User’s Manual for a complete listing of indications, contraindications, warnings, precautions, potential adverse events and directions for use.

 

Indications and Usage: The CardioMEMS™ HF System is indicated for wirelessly measuring and monitoring pulmonary artery (PA) pressure and heart rate in New York Heart Association (NYHA) Class III heart failure patients who have been hospitalized for heart failure in the previous year. The hemodynamic data are used by physicians for heart failure management and with the goal of reducing heart failure hospitalizations.

 

Contraindications: The CardioMEMS HF System is contraindicated for patients with an inability to take dual antiplatelet or anticoagulants for one month post implant.

 

Potential Adverse Events: Potential adverse events associated with the implantation procedure include, but are not limited to the following: Air embolism, Allergic reaction, Abnormal heart rate or rhythm, Bleeding, Bruising, Chest pain, Nausea, Stroke, Infection, Sepsis, Delayed wound healing, Atrial Dysrhythmia, Thrombus formation, Hematoma, Venous trauma, Valve damage, Pulmonary infarct, Pulmonary embolism, Heart attack (myocardial infarction), Death, Hemoptysis. Sensor does not detach from delivery system.

SJM-MEM-1014-0041(1)a(1)

Last Updated: January 02, 2019

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